3厂家厄贝沙坦片体外溶出度考察

Comparison of the Dissolution of Irbesartan Tablets from 3 Pharmaceutical Manufacturers in Vitro

目的:比较不同厂家生产的厄贝沙坦片的体外溶出度。方法:采用转篮法进行体外溶出度试验,以紫外分光光度法在244nm波长处进行测定,计算累积溶出百分率,并以威布尔方程拟合溶出参数T50、Td、T80、m,对参数进行方差分析。结果:3厂家厄贝沙坦片45min的累积溶出百分率均超过95%,均符合2010年版《中国药典》规定,但各厂家产品T50、Td、T80、m间均有显著性差异(P<0.01)。结论:不同厂家厄贝沙坦片的溶出参数存在差异,药品采购及临床用药时应加以注意。

OBJECTIVE： To compare the in vitro dissolution of Irbesartan tablets from 3 different pharmaceutical manufacturers. METHODS： The dissolution test was carried out with rotating basket. The concentration of irbesartan was determined by UV spectrophotometry at detection wavelength of 244 nm. The accumulative dissolution was calculated and the Weibull’s equation was used to model the dissolution parameters （T50, Td, T80, m）. The difference between different groups was statistically evaluated by variance analysis. RESULTS： The accumulative dissolution percentages of irbesartan from 3 pharmaceutical manufacturers were more than 95% at 45 min, and conformed to the requirements of Chinese Pharmacopoeia （2010 edition）. But significant differences were found among dissolution parameters （T50, Td, T80, m） （P〈0.01） of irbesartan preparations from different factories. CONCLUSION： There is significant difference in dissolution parameters among irbesartan preparations from different manufacturers. It should be paid attention to clinical use of drugs.